The Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) has issued an Untitled Letter to Eli Lilly for a violative Instagram post regarding its drug, Trulicity®. The post was also reported to the FDA Bad Ad Program and is the first OPDP letter issued in 2022.
According to the Untitled Letter, the Instagram post is misleading because the video portion of the post prominently communicates the benefits of Trulicity, but fails to adequately communicate Trulicity’s FDA-approved indication and the drug's limitations of use, particularly that Trulicity has not been studied in patients with a history of pancreatitis and should not be used in patients with type 1 diabetes mellitus or in patients with severe gastrointestinal problems. The Letter notes that "[b]y failing to adequately communicate the indication and limitations of use associated with Trulicity, the post creates a misleading impression about the scope of the FDA-approved indication. This is particularly concerning given the serious risks of this product and the suggestion that Trulicity will help 'lower A1C' in all patients when this has not been demonstrated."
OPDP further notes that the post presents benefit claims using "colorful, compelling, and attention-grabbing fast-paced visuals that take up the majority of the post in a video." However, the risk information is provided in a small window relegated to the bottom of the screen that scrolls rapidly using small font that is difficult to read and hard for consumers to understand.
According to the agency, the overall effect of the presentation creates a misleading impression of the drug's safety, and is "especially problematic from a public health perspective given the serious risks associated with the drug." OPDP requests a response from Eli Lilly within 15 days that addresses the concerns described in the Untitled Letter and explains the company's plan for discontinuing use of such communications or for ceasing distribution of the drug.
A copy of the Untitled Letter is available here.
For more information regarding FDA Enforcement Letters, please see the OPDP Promotional Violations section of the Enforcement Actions Database.